DCB 0129 and 0160,
signed off in 4 weeks.
If your digital health product is going live in the NHS, you need a clinical safety case. I'm a practising NHS doctor and a contracted CSO. Fixed scope, fixed fee, no surprises, no theatre.
No safety case,
no NHS go-live.
DCB 0129 (for manufacturers) and DCB 0160 (for deploying organisations) are information standards under section 250 of the Health and Social Care Act 2012, and they apply to most health IT used in the NHS. Where they apply, the practical rule is blunt: no clinical safety case, no DTAC pass, no procurement, no live deployment.
Most early-stage SaMD teams underestimate this. The cost is not the consultancy fee — it's the slipped go-live and the cancelled trust pilot. This engagement exists to keep that timeline intact: a DCB 0129 consultant and DCB 0160 consultant who is also a practising NHS doctor, so the safety case is written by someone who works inside the workflows it has to be safe in. Comparing providers? Read how to choose a DCB 0129 consultant. If the wording is AI as a medical device or SaMD route mapping, use the AI medical-device consultant page. New to the role? Read what a Clinical Safety Officer does. Need an external signatory route? See independent CSO support →
What you get.
A complete clinical safety case package, ready to submit to your deploying NHS organisation — with a CSO signature on the line.
What the package includes
Clinical Safety Case Report
DCB 0129-conformant CSCR: intended use, scope, safety claims, hazard summary and residual risk justification. Written and evidenced the way clinical safety committees expect to see it.
~10-page report CSCR and hazard log details →Hazard log & Clinical Risk Management File
Full CRMF with hazard identification workshop, risk evaluation matrix, mitigation traceability, and pre/post-mitigation risk scores. Maintained as a live document.
~30 hazards typicalSafety requirements specification
Engineering-actionable safety requirements, mapped to your hazards. Your dev team gets a clear backlog; your auditor gets traceability.
JIRA / Linear-readyGo-live release memo
Signed CSO release memo confirming residual risk acceptability — the document your deploying trust actually wants to see before they switch you on.
Signed by CSOPost-market surveillance plan
The written PMS plan required by DCB 0129 and DTAC: incident review process, trigger thresholds and reporting cadence, ready to hand to your team. Running the surveillance and reviewing safety after go-live is a separate engagement — see below.
Plan documentDTAC and DSPT cross-walk
If you also need DTAC or DSPT (most do), I'll map your DCB outputs to those frameworks so you don't duplicate work.
£180 / hr DTAC clinical safety support →Why the fee is the fee.
£8,500 buys an accountable clinician's signature on a safety case prepared for your deploying NHS organisation's clinical safety review — and the complete, audit-ready evidence pack behind it. Here is what that price actually covers.
A name on the line
A DCB 0129 safety case is only worth the clinician who signs it. You're buying a registered NHS doctor and contracted Clinical Safety Officer taking personal, accountable ownership of residual clinical risk — not a template with a logo on it.
Written from the clinic floor
Hazards are identified by someone who has run the workflows your product sits inside — trauma, clinics, theatres, the front door. That is the difference between a safety case that answers the committee's questions up front and one that comes back covered in them.
A fixed fee that protects your runway
One number, agreed up front, for the full pre-go-live package. No day-rate drift, no surprise invoices. You can put £8,500 and four weeks in the board pack and trust both.
Four weeks to a signed memo
A defined, repeatable process gets you to a signed go-live release memo in four weeks — fast enough to protect a pilot deadline, rigorous enough to survive an audit. The pace comes from method, not from cutting corners.
Evidence a regulator can follow
You receive the full clinical risk management file — CSCR, hazard log, safety requirements, PMS plan and release memo — handed over in a version-tracked folder, traceable end to end and ready for DTAC and trust submission.
The CSO who already knows your product
When you ship a major change or a new hazard appears after go-live, the clinician signing it off is the one who already understands your system — no re-onboarding, no second discovery phase.
Exactly what's in, and what's not.
Clear boundaries are what keep a fixed fee fixed. The package below is the defined pre-go-live clinical safety work. Anything beyond it is genuinely separate work, scoped and priced on its own — so neither of us is surprised.
- Clinical safety case report (CSCR), DCB 0129-conformant
- Clinical risk management file & hazard log (CRMF)
- One facilitated hazard identification workshop
- Safety requirements specification, mapped to hazards
- Written post-market surveillance plan
- Signed CSO go-live release memo
- Up to three meetings and two rounds of revisions on the deliverables
- Audit-ready handover in a version-tracked folder
- Running post-market surveillance after go-live
- Safety reviews, incident reviews and hazard log updates post-launch
- Sign-off of major product changes or newly identified hazards
- DTAC and DSPT cross-walks and submissions
- Recurring clinical governance meetings
- Re-work driven by major scope changes mid-engagement
- Standing as named CSO for the deploying organisation under DCB 0160
- Regulatory work beyond DCB 0129 / 0160 (e.g. UKCA/MDR)
Post-go-live work is billed at £180/hr, or by optional monthly retainer. The boundary is the go-live release memo: everything up to and including it is fixed-fee; everything after it is separate.
The right fit — and the honest mismatch.
Built for these teams
Digital health and SaMD manufacturers approaching an NHS go-live or trust pilot; founders and CTOs who need a DCB 0129 clinical safety case to pass DTAC and procurement; teams who want a single accountable clinician rather than a faceless compliance shop.
When I'll point you elsewhere
If your product isn't health IT used within the NHS, if you need a full quality management system or UKCA/MDR conformity rather than DCB clinical safety, or if you need a permanent in-house CSO, I'll say so on the first call — and refer you on where I can.
Four weeks, three meetings.
The four-week sequence
Discovery & scope
90-minute kickoff. I learn your product, your users, your deployment context. You get a draft scope and a fixed quote within 48 hours.
Hazard workshop
Half-day workshop with your clinical and engineering leads. We work through the hazard log together. By the end you have a populated CRMF.
Drafting
I write the CSCR, safety requirements and PMS plan. You stay heads-down on shipping. One short check-in mid-week.
Sign-off
Final review, residual risk acceptance, signed release memo. Package handed over in a Git-tracked folder, ready for DTAC and trust submission.
One number for the package.
One number for everything else.
No timesheet games, no scope creep on the deliverables. The fixed fee covers the defined pre-go-live clinical safety work; everything after go-live is scoped separately, so you know the cost before we start.
One fixed fee for the complete pre-go-live clinical safety case, signed off by an accountable NHS clinician: CSCR, CRMF, hazard log, safety requirements spec, post-market surveillance plan, and the signed go-live release memo your trust wants to see. Four-week turnaround, up to three meetings and two rounds of revisions.
Priced to put in a board pack with confidence. Excludes post-go-live work (below). Full cost guide →Post-go-live work is not included in the package. Running post-market surveillance, safety reviews after go-live, incident reviews, hazard log updates, sign-off of major product changes or new hazards, DTAC and DSPT cross-walks, and recurring governance meetings are billed hourly, or by optional retainer if you'd prefer a fixed monthly arrangement.
Hours logged transparently. Billed monthly. Named CSO retainer details →Common questions.
What is a Clinical Safety Officer?
A registered clinician, trained in clinical risk management, who is accountable for the clinical safety of a health IT system. DCB 0129 and 0160 require a named CSO to review and sign off the clinical safety case before NHS go-live. I'm a practising NHS doctor and contracted CSO based in England. Read the CSO explainer →
Do I really need DCB 0129?
If your product is health IT used by or within the NHS, DCB 0129 almost certainly applies to you as the manufacturer — and your deploying organisation carries its own DCB 0160 duties. Where it applies, no safety case means no DTAC pass, no procurement, no go-live. Not sure whether it applies to you? That is the first thing I check, before any engagement.
How fast can this be done?
Four weeks from kickoff to signed release memo, if your team shows up to one kickoff and one half-day hazard workshop. The package is fixed-scope and fixed-fee, so the timeline doesn't drift.
What happens after launch?
The fixed-fee package ends at go-live. Ongoing post-market surveillance, safety reviews after go-live, incident reviews, hazard log maintenance, sign-off of major product changes or new hazards, and recurring governance are not included — they're billed hourly at £180/hr, or by optional retainer. For supplier-side named CSO support, see contract Clinical Safety Officer support; for external or independent CSO language, see independent Clinical Safety Officer.
Start with the practical guides.
Pilot deadline already in the calendar?
Send me the product, the timeline and the trust you're deploying into. I'll reply within 24 hours with a yes, a no, or a referral.